Wireless modules are increasingly being integrated into everyday products, like refrigerators, cars, and consumer medical devices. Therefore, more manufacturers need to be aware of the regulatory requirements of wireless transmitters.
In the European Union, it is mandatory that radio equipment meets the requirements for the Radio and Telecommunications Terminal Equipment Directive (R&TTE) 1999/5/EC (replaced in June 2016 by the Radio Equipment Directive 2014/53/EC).
The manufacturer of the wireless-enabled product is responsible for its overall compliance. Module manufacturers must provide clear instructions of integration to any host product manufacturer.
Since the R&TTE Directive does not make specific reference to wireless modules, there are no strict rules to follow, but there are a few general guidelines to keep in mind:
- When an R&TTE compliant module is integrated into a final host product, no further radio compliance testing is required, provided the module is integrated in accordance with its manufacturer’s instructions
- The final host product must always meet the other essential safety and EMC requirements of the directive
- The most common method of demonstrating compliance and a presumption of conformity with R&TTE is by using harmonized standards
The R&TTE Compliance Association has issued guidance on the use of wireless modules: Technical Guidance Note 01 on the R&TTED compliance requirements for a Radio Module and the Final Product that integrates a Radio Module, May 2013.
In the U.S. and Canada, the approval process is straightforward, unless there are multiple modules integrated together.
The Federal Communications Commission’s (FCC) rules on module integration are explained in CFR 47 Part 15.212, with further detail in the guidance document KDB 996369. The Industry Canada rules for modules are similar to those of the FCC and are spelled out in RSS-GEN Section 3.
In order for a wireless module to meet the requirements of FCC Part 15, it must comply with the requirements for shielded circuitry, a unique antenna connector, stand-alone configuration, and RF exposure limits. Once these guidelines are met, FCC modular approval is granted through a TCB like MET Labs, and the product may be operated under certain conditions of use. If the conditions of the grant are met, further testing is not required for the intentional radiator part of the host equipment.
Where multiple modules are integrated together, the rules can become more complex. This is particularly true if the host device is to be used in a portable application within 20cm of the human head or body and RF exposure becomes a major issue. Then SAR testing is required.
Where the conditions of the modular grant cannot be adhered to when integrated into the final host, additional testing and certification is usually required.
To learn more about wireless compliance, attend our upcoming EMC & Wireless Design and Testing Seminar in Santa Clara, CA. If you have an upcoming need for wireless equipment testing or compliance assistance, contact us today.
When an RF product is revised due to obsolete parts, cost cutting, or product improvements, how does the engineer know what the FCC requirements are for the altered product? Will it require a new FCC filing and ID number or will a Permissive Change be allowed?
To allow products to be modified without requiring a new filing, the FCC has defined three Permissive Change options listed in Title 47 Part 2.1043, KDB 178919 D01 Permissive Change Policy v05r04.
Class I Permissive Change
This class includes modifications which do not degrade the characteristics accepted by the FCC when certification is granted. No filing with the Commission is required for a Class I Change.
Class II Permissive Change
This class includes modifications which degrade the performance characteristics as reported to the FCC at initial certification. In this case, the grantee must supply the Commission with results of tests of characteristics affected by the change.
Class III Permissive Change
This class includes software modifications of a software-defined radio transmitter that change the frequency range, modulation type or maximum output power (either radiated or conducted) outside the parameters previously approved.
In this case, the grantee must supply the FCC with a description of the changes and test results showing that the equipment complies with applicable rules with the new software loaded, including compliance with applicable RF exposure requirements.
Class III changes are permitted only for equipment on which no Class II changes have been made from the originally approved device.
For any of these changes, modified equipment cannot be marketed under the existing grant of certification prior to acknowledgment by the Commission that the change is acceptable.
In summary, changes to a modular radio or product will result in either a Permissive Change or a new FCC filing and ID number. The degree of change will determine both the process and the amount of supporting data required to illustrate compliance.
With few exceptions, a new FCC ID and a new equipment authorization application will be required in the event of changes to the basic frequency (including clock and data rates), frequency multiplication stages, basic modulator circuit, or maximum power or field strength ratings.
Just like last year, the Compliance Today blog for electrical product manufacturer compliance engineers saw a significant increase in readers and subscribers for 2014. Following were the most popular posts, by pageviews.
- IEC 60601-1-2 4th Edition for Medical EMC Has Immunity & Risk Management Changes
- EN 61326-1: 2013 Replacing 2006 Version for EMC Directive Evaluation of Lab, Test & Measurement Equipment
- EN55032 Replacing EN55022 and Others for CE Marking of Multimedia Equipment
- New Radio Equipment Directive Adopted by EU, Awaits Publication in OJ
- CE Marking Directives Recast to Align with New Legislative Framework
- IEC 60601-1 3rd Edition for Medical Electrical Equipment Continues to Gain Adoption in Global Markets
- Some Electronic Devices Are Exempt from FCC EMC Testing
- Top 20 Non-Compliance Findings for Panel & Motor-Operated Equipment
- EMI/EMC Testing Best Practices – Before & During Your Lab Visit
- Radio Equipment Directive (RED) Replacing R&TTE Directive, is Published in OJ
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Want more in-depth information on one of these topics? Check to see if we are planning a seminar or webinar on it.
Need electrical product testing? Fill an RFQ.
On October 16, 2014 the FCC published 726920 D01 Confidentiality Request Procedures, a new document that details the steps required to ensure proprietary information about your device will be held confidential.
To be granted confidentiality, your application must include a reference to 0.457(d) and 0.459 of the FCC Rules, the reason why the information should be held from the public, specific confidential information by exhibit type, name, and description, an indication if the information is a “trade secret,” a signature, and the type of confidentiality requested. Confidentiality Letters must specifically reference the documents you wish to withhold from the public.
The two types of confidentiality are long term and short term.
Under long term confidentiality, the following exhibits are held private without filing a request:
- Software defined radio, cognitive radio attachments submitted into the SDR software, security info exhibit type
- Scanning receiver information included in one of the exhibits noted as “commonly held confidential” and scanning receiver internal photos
Under long term confidentiality, the following exhibits can be held private upon request:
- Block diagrams
- Operational descriptions
- Parts list/tune up info
Under short term confidentiality, exhibits held private are the same as long term confidentiality, plus:
- External photos
- Test set up photos
- Internal photos
- User manuals
Short term confidentiality can only last up to 180 days. If you request short term confidentiality but market your device before the 180 day period is over, you must notify your Telecommunication Certification Body (TCB) so your confidentiality request can be removed.
If you are seeking confidentiality for an exhibit not listed above, you are able to petition the FCC and all approvals are made on a case-by-case basis.
Read about how Some Electronic Devices Are Exempt from FCC EMC Testing.
The FCC released a First Report and Order (ET Docket No. 13-49) on April 1, 2014 allowing devices in the U-NII-1 band to operate with higher power. The R&O also allows this band to be used outdoors, whereas this has only been an indoor band previously. Some of the key points in the First R&O are:
- Devices operating in the U-NII-1 band will be allowed 30 dBm (1 W) conducted power, a PSD of 17 dBm/MHz and an allowance of a 6 dBi antenna. However, the maximum EIRP above 30 degrees elevation is limited to 21 dBm.
- The upper edge of the U-UNII-3 band has been extended by 25 MHz. Therefore, the band is now 5.725 – 5.850 GHz which is in line with the 15.247 DTS band. Both rule parts will be consolidated.
- Bin1 radar waveform will be updated to better account for actual Terminal Doppler Weather Radar (TDWR) waveforms.
For equipment that is already certified, a Class II Permissive Change may be performed to update the device to the new rules. A Class II PC is performed when there are changes to the radio, such as addition of new antenna or if a rule change allows for additional provisions.
The new rules will take effect 30 days after being published in the Federal Register. The publish date is expected soon.
The FCC has also updated the TCB Exclusion list. The exclusion list is now “empty.” Therefore, TCBs can now grant almost all applications, including equipment operating in the DFS bands and UWB equipment. However, TCBs will have to follow a Permit But Ask (PBA) procedure with the FCC to grant these devices. DFS equipment will still be independently tested by the FCC as before. But this is still expected to reduce the time to market for manufacturers.
The R&TTE Directive is getting a face lift. It will now be called simply the Radio Equipment (RE) Directive. Telecommunications equipment will be moved over to the EMC Directive. The RE Directive will be limited to wireless RF transmitter devices and receivers. The use of the exclamation mark (i.e. !) and the NB number (if applicable) will not be required adjacent to the CE mark.
EN 300 328 v1.8.1 will become effective end of the year and any new radio device placed on or after this date will need to meet the new standard. The previous version of the standard will cease to give presumption of conformity with the requirements for Article 3(2) of the Radio Equipment Directive.
Body SAR will be required for Japan starting April 1, 2014. The limit is 2 W/kg for body and 4 W/kg for arms and legs. The SAR is calculated over any 10g of tissue (as compared to 1g of tissue for FCC). Body SAR will be exempt for radio devices that have less than 20mW output power. The test method, for the most part, is harmonized with IEC 62209-2. Read about SAR requirements in North America and Europe.
There is a second FCC Notice of Proposed Rulemaking (NPRM) coming out early next year proposing still-unknown new certification procedures for FCC. This is in addition to the first NPRM that issued in February 2013 and which included significant changes to the FCC equipment authorization process. FCC is calling it a “complete overhaul of the certification process.” It is expected these changes will take effect in late 2014.
Mexico and Israel MRAs
Mexico and Israel Mutual Recognition Agreements (MRAs) should be finalized late next year. When Phase I of the MRAs are implemented, U.S. manufacturers will be able to perform testing at a local U.S. lab for those countries. Later, when Phase II is implemented each country will be able to certify products for the other.
For questions about these changes or for an immediate test need, visit our Quote Center.
Register now for MET’s free EMC & Wireless Design & Testing Seminar in Baltimore next week.
Due to rapid growth in medical devices that incorporate RF wireless technology, on August 14 the Food and Drug Administration (FDA) released final guidance for integrating radio frequency (RF) wireless technology in medical
devices. The guidance is recommended, but not mandatory.
FDA said its recommendations cover devices that are implanted or worn on the body, and others intended for use in locations such as hospitals and clinical laboratories.
The guidance discusses issues that may affect the safe and effective use of medical devices that incorporate RF wireless technology, including electromagnetic compatibility (EMC).
The use and deployment of RF wireless technology in and around medical devices is an increasing concern because the electromagnetic environments where medical devices are used might contain many sources of RF energy, and the RF wireless emissions from one product or device could potentially affect the function of another, the agency said.
FDA says these issues should be considered for all medical devices that incorporate RF wireless technology, such as Wireless Medical Telemetry Service (WMTS); Medical Device Radiocommunication Service (MedRadio) as well as Medical Micropower Network (MNN) and Medical Body Area Network (MBAN); cellular communication chipsets; and RF identification (RFID) products.
FDA recommends that EMC be an integral part of the development, design, testing, and performance for RF wireless medical devices. Beyond FCC requirements, FDA recommends using risk analysis to identify any potential issues associated with EMC and determining risk acceptability criteria based on information about the device and its intended use, including foreseeable misuse, sources of environmental EMD (e.g., radio transmitters, computer RF wireless equipment), and the potential for RF emissions to affect other devices.
IEC 60601-1-2 is a FDA-recognized consensus standard for EMC, but it does not adequately address whether the wireless communications will operate properly in the presence of in-band EMD (e.g., other RF emissions overlapping the frequency band utilized by the medical device wireless signals). Therefore, the medical device’s wireless communication(s) should be actively transmitting while testing for susceptibility during all EMC immunity testing.
EMC considerations for active implantable medical devices are covered under documents such as the ISO 14708-1 standard (see Appendix B).
FDA worked closely with the Federal Communications Commission (FCC) to develop this guidance.
MET Labs teamed with FDA on a voluntary Program to Test Medical Devices for RFID Interference. Find out more about the Program.
MET’s Annual Global Compliance Seminar in September will include a session on Electrical Medical Equipment Approvals for EU. Register here.
The U.S. Federal Communications Commission (FCC) has proposed important changes to its equipment testing and authorization program under Part 15 and Part 68 of its rules. The FCC says the changes will streamline the approval process and expedite the introduction of new devices to the market.
In a Notice of Proposed Rulemaking issued last month, the FCC proposed a number of changes to its existing equipment authorization program. The key proposed changes include:
TCB Accreditation – Telecommunications certification bodies (TCBs) – like MET Labs – will be accredited in accordance with the requirements of ISO/IEC 17011 and ISO/IEC 17065. These standards replace ISO/IEC Guides 58, 61 and 65.
Testing Laboratories Accreditation – Laboratories that test equipment subject to certification or approval under any of its rules must be accredited to ISO/IEC 17025.
TCB Authority – The FCC will no longer directly issue any grants of equipment authorization. Instead, TCBs will authorize and deny all products subject to certification.
Post-Market Surveillance – For post-market surveillance, the FCC will specify the number and types of samples that a TCB must test.
Assessing TCB Performance – NIST will assess TCB performance. The Commission also outlined a process to address TCB non-performance issues.
Measurement Procedures – ANSI C63.10-2009 will be the procedure used to determine the compliance of intentional radiators, and ANSI C63.4-2009 will be the procedure for assessing unintentional radiators.
We understand these proposed changes are likely to go through without significant modification, but first there is a comment period to elicit feedback. Comments on the Commission’s proposed rule changes are due by late March here.
Read the complete text of the FCC’s Notice of Proposed Rulemaking regarding important changes to its equipment testing and authorization program under Part 15 and Part 68.
MET Labs is an accredited testing laboratory and TCB. Contact us for FCC Testing or Certification assistance.
In June, the Federal Communications Commission (FCC) announced it would review its rules on radiation exposure from cell phones. The FCC’s current Specific Absorption Rate (SAR) limits were set fifteen years ago, in 1996.
Any day now, the FCC is expected to publish a Notice of Inquiry, which will be open to public comment for a couple months. After that, the commission may issue some proposed rules. After another comment period, the FCC could issue a final rule.
It is unlikely there will be a change to the SAR regulations. The last time the FCC proposed a change to its RF rules was in 2003, and these minor-change amendments are still pending.
The FCC’s current SAR limits are already the tightest in the world. SAR is the rate at which your body absorbs energy from a radio-frequency magnetic field. It’s measured in watts per kilogram or W/kg. To be considered safe, every cell phone model sold in the U.S. must adhere to a SAR that’s less than 1.6 watts per kilogram taken over a volume containing a mass of 1 gram of tissue, even under the worst conditions.
The likely reason for the review of the cell phone radiation exposure rules now? The Government Accountability Office (GAO) has been looking into the adequacy of the cell phone standard, and the FCC wants to be seen as proactive in this area.
Read about MET’s SAR Testing capabilities.
The U.S. Federal Communications Commission (FCC) has issued draft revisions to six Knowledge Database (KDB) publications for RF exposure and SAR compliance.
KDB Publication 447498 – General RF Exposure Policies for Equipment Authorization
KDB Publication 941225 – SAR Evaluation Considerations for LTE Devices
KDB Publication 865664 – SAR Measurement Requirements, Compliance Reporting and Documentation for 100 MHz – 6 GHz
KDB Publication 616217 – SAR Evaluation Considerations for Laptop, Notebook, Netbook and Tablet Computers
KDB Publication 648474 – SAR Evaluation Considerations for Handsets with Multiple Transmitters and Antennas
KDB Publication 643646 – RF Exposure Evaluation Considerations for Occupational Push-to-Talk Two-Way Radios
The public may post a comment on these proposed revisions through June 1, 2012.
Other RF Exposure KDBs
Remaining RF exposure KDB publications that do not have draft revisions are:
- KDB Publication 248227 – Additional SAR Measurement Procedures that Specifically Address 802.11 a/b/g Devices
- KDB Publication 615223 – SAR Requirements and Procedures for 802.16e/WiMax Devices
- KDB Publication 450824 – SAR Probe Calibration and System Verification Considerations for Measurements from 150 MHz to 3 GHz
- KDB Publication 680106 – Rules Regulating Short Distance Wireless Inductive Coupled Charging Pads or Charging Devices
Questions about SAR compliance? A SAR testing expert will be available next week at 2012 International CTIA Wireless at the MET Labs exhibit.